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The primary objective of this study is to confirm the efficacy of a single oral 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day.
The study is a prospective, randomized, parallel group, double-blind, placebo-controlled study to confirm the efficacy and the safety of the oxytocin receptor antagonist, nolasiban, in 760 women undergoing fresh embryo transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nolasiban 900 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nolasiban 900mg | Drug | Nolasiban dispersible tablets for single oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-uterine pregnancy with fetal heart beat at 10 weeks | Intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day | 10 weeks post ET day |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth | Live birth after 24 weeks of gestation | Up to 42 weeks of gestation |
| Miscarriage | Any clinical pregnancy that does not result in a live birth prior 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Frequency and severity of treatment emergent adverse events | Through study completion, up to 11 months |
| Neonatal assessments | Incidence of any malformation or any significant morbidity during the neonatal period |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ObsEva SA | Geneva | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator ID 1001 | Brussels | Belgium | ||||
| Investigator ID 1002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33534895 | Derived | Griesinger G, Blockeel C, Pierzynski P, Tournaye H, Visnova H, Humberstone A, Terrill P, Pohl O, Garner E, Donnez J, Loumaye E. Effect of the oxytocin receptor antagonist nolasiban on pregnancy rates in women undergoing embryo transfer following IVF: analysis of three randomised clinical trials. Hum Reprod. 2021 Mar 18;36(4):1007-1020. doi: 10.1093/humrep/deaa369. |
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Double Blind
| Placebo |
| Drug |
Placebo dispersible tablets for single oral administration |
|
| From 6 weeks post ET to 24 weeks gestation |
| Intra-uterine pregnancy at 6 weeks | Intra-uterine pregnancy with fetal heart beat at 6 weeks post ET day | 6 weeks post ET |
| Positive blood pregnancy test | Positive blood pregnancy test at 14 days post oocyte pick-up (OPU) | 14 days post OPU |
| Birth of infant until 28 days |
| ASQ-3 | Ages and Stages Questionnaire-3 (ASQ-3) domain score(s) at 6 months, adjusted for gestational age at birth | 6 months after term |
| Brussels |
| Belgium |
| Investigator ID 1003 | Brussels | Belgium |
| Investigator ID 1004 | Brussels | Belgium |
| Investigator ID 1107 | Olomouc | Czechia |
| Investigator ID 1101 | Prague | Czechia |
| Investigator ID 1102 | Prague | Czechia |
| Investigator ID 1103 | Prague | Czechia |
| Investigator ID 1104 | Prague | Czechia |
| Investigator ID 1108 | Prague | Czechia |
| Investigator ID 1109 | Teplice | Czechia |
| Investigator ID 1106 | Zlín | Czechia |
| Investigator ID 1204 | Copenhagen | Denmark |
| Investigator ID 1205 | Herlev | Denmark |
| Investigator ID 1202 | Hvidovre | Denmark |
| Investigator ID 1203 | Skive | Denmark |
| Investigator ID 1301 | Tartu | Estonia |
| Investigator ID 1303 | Tartu | Estonia |
| Investigator ID 1401 | Helsinki | Finland |
| Investigator ID 1402 | Helsinki | Finland |
| Investigator ID 1403 | Oulu | Finland |
| Investigator ID 1501 | Heidelberg | Germany |
| Investigator ID 1502 | Lübeck | Germany |
| Investigator ID 1504 | Mainz | Germany |
| Investigator ID 1503 | Marburg | Germany |
| Investigator ID 1601 | Budapest | Hungary |
| Investigator ID 1604 | Budapest | Hungary |
| Investigator ID 1603 | Pécs | Hungary |
| Investigator ID 1602 | Tapolca | Hungary |
| Investigator ID 1701 | Bialystok | Poland |
| Investigator ID 1703 | Bialystok | Poland |
| Investigator ID 1705 | Bialystok | Poland |
| Investigator ID 1702 | Katowice | Poland |
| Investigator ID 1704 | Szczecin | Poland |
| Investigator ID 1706 | Warsaw | Poland |
| Investigator ID 1801 | Barakaldo | Spain |
| Investigator ID 1805 | Barcelona | Spain |
| Investigator ID 1808 | Barcelona | Spain |
| Investigator ID 1809 | Leioa | Spain |
| Investigator ID 1804 | Madrid | Spain |
| Investigator ID 1807 | Madrid | Spain |
| Investigator ID 1811 | Seville | Spain |
| Investigator ID 1806 | Valencia | Spain |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C000618265 | nolasiban |
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